NCT03394534

Brief Summary

The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are:

  1. 1.To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home
  2. 2.To investigate staff and older adults' perception of CGA programme
  3. 3.To assess the health care resource usage and cost of the CGA programme
  4. 4.To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

December 18, 2017

Last Update Submit

May 17, 2022

Conditions

Frailty

Keywords

Comprehensive Geriatric AssessmentFrailtyelectronic Frailty IndexeFICare and Support planPrimary Care

Outcome Measures

Primary Outcomes (1)

  • Hospitalisation and Nursing Home Admissions

    Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted

    at 6 months post intervention

Secondary Outcomes (8)

  • Functional Status

    at baseline and 6 months post intervention

  • Loneliness

    at baseline and 6 months post intervention

  • Health related Quality of Life

    at baseline and 6 months post intervention

  • Number of 999 calls and A+E attendance during the 6 months period

    at 6 months post intervention

  • Length of time spent on A+E during the 6 months period

    at 6 months post intervention

  • +3 more secondary outcomes

Study Arms (2)

CGA group

EXPERIMENTAL
Other: CGA group

Treatment as Usual

NO INTERVENTION

Interventions

CGA groupOTHER

CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)

CGA group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 to 95 years
  • eFI score \> 0.12

You may not qualify if:

  • Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Derby

Derby, DE22 1GB, United Kingdom

Location

Related Publications (6)

  • Edmans J, Bradshaw L, Gladman JR, Franklin M, Berdunov V, Elliott R, Conroy SP. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units. Age Ageing. 2013 Nov;42(6):747-53. doi: 10.1093/ageing/aft054. Epub 2013 May 10.

    PMID: 23666405BACKGROUND

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PMID: 23395245BACKGROUND

  • Gladman JR, Conroy SP, Ranhoff AH, Gordon AL. New horizons in the implementation and research of comprehensive geriatric assessment: knowing, doing and the 'know-do' gap. Age Ageing. 2016 Mar;45(2):194-200. doi: 10.1093/ageing/afw012.

    PMID: 26941353BACKGROUND

  • Fit for Frailty - Developing, commissioning and managing services for people living with frailty in community settings - a report from the British Geriatrics Society and the Royal College of General Practitioners 2015.

    BACKGROUND

  • Clegg A, Rogers L, Young J. Diagnostic test accuracy of simple instruments for identifying frailty in community-dwelling older people: a systematic review. Age Ageing. 2015 Jan;44(1):148-52. doi: 10.1093/ageing/afu157. Epub 2014 Oct 29.

    PMID: 25355618BACKGROUND

  • Safari R, Jackson J, Boole L. Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial. BMC Geriatr. 2023 Aug 24;23(1):513. doi: 10.1186/s12877-023-04218-0.

    PMID: 37620760DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Reza Safari, PhD

    University of Derby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 9, 2018

Study Start

January 15, 2019

Primary Completion

June 15, 2019

Study Completion

September 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)